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SAM.gov SOURCES SOUGHT NOTICE Solicitation Number: 75N95023Q00044 Title: Early Markers of Alzheimer’s Disease: PET Radiotracer Acquisition in the Baltimore Longitudinal Study of Aging (BLSA) Classific... SAM.gov SOURCES SOUGHT NOTICE Solicitation Number: 75N95023Q00044 Title: Early Markers of Alzheimer’s Disease: PET Radiotracer Acquisition in the Baltimore Longitudinal Study of Aging (BLSA) Classification Code: 6505 – Drugs and Biologicals NAICS Code: 325412 Description: Pharmaceutical Preparation Manufacturing This is a Sources Sought Notice. This is NOT a solicitation for proposals, proposal abstracts, or quotations. The purpose of this notice is to obtain information regarding the availability and capability of all qualified sources to perform a potential requirement. This notice is issued to help determine the availability of qualified companies technically capable of meeting the Government requirement and to determine the method of acquisition. It is not to be construed as a commitment by the Government to issue a solicitation or ultimately award a contract. Responses will not be considered as proposals or quotes. No award will be made as a result of this notice. The Government will NOT be responsible for any costs incurred by the respondents to this notice. This notice is strictly for research and information purposes only. Background: Advances in molecular imaging with positron emission tomography (PET) have allowed a window into the hallmark pathologies of AD in living humans. The ability to image amyloid plaques and tau tangles in vivo is impacting the conduct of clinical trials, including verifying target engagement, informing patient selection, and advancing therapeutic monitoring and outcomes. Importantly, PET molecular imaging tools also are now widely applied in research studies of individuals without cognitive impairment to identify the earliest stages of AD and elucidate the temporal sequence of events leading to cognitive impairment and AD. Information on biomarker status also provides the opportunity to study age-related cognitive changes in individuals without (as well as with) AD pathology. The National Institute on Aging (NIA) initiated amyloid PET imaging with Pittsburgh compound B (PiB) in the Baltimore Longitudinal Study of Aging (BLSA) in 2005 and tau PET imaging with AV-1451 (T-807) in 2016. Consistent with autopsy data from BLSA and other studies, approximately 30% of cognitively normal individuals have detectable amyloid deposition in the brain on amyloid PET imaging. Individuals with higher levels of ?-amyloid are older, more likely to carry the Apolipoprotein E ?4 allele, have greater longitudinal decline in memory and other cognitive functions, and are more likely to accumulate amyloid and show tau progression over time. In addition, through the BLSA autopsy program, we have shown the correspondence between in vivo imaging and post-mortem values of amyloid burden. Work by our group has been central to defining the relationship between amyloid burden and memory change, to characterizing the magnitude and spatial pattern of progression of amyloid burden and its relation to tau progression, to highlighting the importance of individuals with intermediate amyloid levels that would be considered PiB negative in many binary classification schemes, and to identifying modifiers of amyloid burden. The NIA has also developed an approach for estimating age at onset of amyloid accumulation, providing an individualized index that can be used as a dependent outcome to assess factors that may modify age at onset of amyloid accumulation. This approach was applied to demonstrate that Apolipoprotein E ?4 genotype is associated with earlier age of onset of amyloid accumulation in the BLSA sample. The BLSA was initiated in 1958 and is a multi-disciplinary study of physiologic and psychologic aspects of normal aging in community-dwelling men and women. Since 1994, the NIA has been conducting a longitudinal brain imaging study of selected older adults in the BLSA to characterize individual differences in longitudinal brain changes, to investigate the extent to which these brain changes underlie individual differences in cognitive aging, to identify brain changes that may be predictors of cognitive decline and Alzheimer’s disease (AD), and to assess the impact of potential modulators of brain and cognitive aging. More recently, the NIA has been using PET scanning to acquire in vivo measures of brain amyloid and tau, the hallmark pathologies of AD. Purpose and Objectives: The purpose of this procurement is the acquisition of FDA- approved amyloid PET radioligand and second generation tau PET imaging radioligand doses. The doses will be used by NIA to perform in-vivo Positron Emission Tomography (PET) scans to measure brain amyloid and tau neuropathology in BLSA participants on a combined PET/computed tomography (CT) scanner. Project requirements: The contractor shall furnish FDA-approved amyloid (Henceforth “amyloid”) PET radioligand doses and second generation tau (Henceforth “tau”) PET imaging radioligand doses in amounts specified by NIA. As NIA cannot predict exactly how many doses will be needed, a range will be provided. Quotes should provide pricing per dose. The estimated amounts per year are as follows: Base Year: MINIMUM: 45 amyloid doses and 45 tau doses. MAXIMUM: 75 amyloid doses and 75 tau doses). Option Year 1: MINIMUM: 45 amyloid doses and 45 tau doses. MAXIMUM: 75 amyloid doses and 75 tau doses). Option Year 2: MINIMUM: 60 amyloid doses and 60 tau doses. MAXIMUM: 95 amyloid doses and 95 tau doses). Option Year 3: MINIMUM: 60 amyloid doses and 60 tau doses. MAXIMUM: 95 amyloid doses and 95 tau doses). Option Year 4: MINIMUM: 60 amyloid doses and 60 tau doses. MAXIMUM: 95 amyloid doses and 95 tau doses). The Contractor must have the capability to deliver both amyloid and tau radioligands to an imaging facility within 15 miles of the NIA Clinical Research Program at Harbor Hospital, Baltimore, MD. Radioligands shall meet quality control standards for human use and shall be prepared and delivered as individual doses timed to specific image acquisition times, accounting for expected radioactivity decay. The Contractor must also provide all information and assistance required for regulatory documents, including materials to meet Institutional Review Board, FDA, and radiation safety regulatory requirements. Anticipated period of performance: Base Year: 12 months Option Year 1: 12 months Option Year 2: 12 months Option Year 3: 12 months Option Year 4: 12 months Requested Response: The intent of this sources sought notice is to define the procurement strategy (e.g. set-aside, sole source, unrestricted) for a solicitation that is intended to be posted soon. Interested contractors are requested to respond by (1) identifying how their proposed product meets or exceeds the project requirements listed above; and (2) providing product literature, white papers, or capability statements that demonstrate their bona fide ability to supply such an item within the time frame described above. In addition, please state your business size status and whether you are the manufacturer or authorized distributor of the item you propose. Please note that NCATS is particularly interested in small business sources. If you are a small business, please state the type of small business (small business; HUBZone; service-disabled, veteran-owned; 8(a); veteran-owned; woman-owned; or small disadvantaged businesses) and your size classification relative to the North American Industry Classification System (NAICS) code for the proposed acquisition. Your responses to the information requested will assist the Government in determining the appropriate acquisition method, including whether a set-aside is possible. The respondent must also provide their DUNS number, organization name, address, point of contact, and size and type of business (e.g., 8(a), HubZone, etc.), pursuant to the applicable NAICS code and any other information that may be helpful in developing or finalizing the acquisition requirements. The information submitted must be must be in an outline format that addresses each of the elements of the project requirements and in the capability statement /information sought paragraphs stated herein. A cover page and an executive summary may be included but is not required. The response must include the respondents’ technical and administrative points of contact, including names, titles, addresses, telephone and fax numbers, and e-mail addresses. All responses to this notice must be submitted electronically to the Contracting Officer. Facsimile responses are NOT accepted. The response must be submitted to Kevin Alvarez, Contracting Officer, at e-mail address kevin.alvarez@nih.gov. The response must be received on or before December 28, 2022, 9:00am, Eastern Time. Disclaimer and Important Notes: This notice does not obligate the Government to award a contract or otherwise pay for the information provided in response. The Government reserves the right to use information provided by respondents for any purpose deemed necessary and legally appropriate. Any organization responding to this notice should ensure that its response is complete and sufficiently detailed to allow the Government to determine the organization’s qualifications to perform the work. Respondents are advised that the Government is under no obligation to acknowledge receipt of the information received or provide feedback to respondents with respect to any information submitted. After a review of the responses received, a presolicitation synopsis and solicitation may be published at beta.SAM.gov. However, responses to this notice will not be considered adequate responses to a solicitation. Confidentiality: No proprietary, classified, confidential, or sensitive information should be included in your response. The Government reserves the right to use any non-proprietary technical information in any resultant solicitation(s).